FDA 510(k)

TNI Clear-Guard 3 angled breathing filter (1545020)

K-Number: K223258 · 2023-06-15

Decision Date2023-06-15

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TNI Clear-Guard 3 angled breathing filter (1545020) is a medical device manufactured by Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under approval number K223258. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TNI Clear-Guard 3 angled breathing filter (1545020)?

TNI Clear-Guard 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Intersurgical , Ltd.. The 510(k) number is K223258.

When was TNI Clear-Guard 3 angled breathing filter (1545020) approved by the FDA?

TNI Clear-Guard 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under approval number K223258.

What company makes TNI Clear-Guard 3 angled breathing filter (1545020)?

TNI Clear-Guard 3 angled breathing filter (1545020) is manufactured by Intersurgical , Ltd..

What is the FDA product code for TNI Clear-Guard 3 angled breathing filter (1545020)?

The FDA product code for TNI Clear-Guard 3 angled breathing filter (1545020) is CAH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.